[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 544 Engrossed in Senate (ES)]
109th CONGRESS
1st Session
S. 544
_______________________________________________________________________
AN ACT
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events
that adversely effect patient safety.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patient Safety and
Quality Improvement Act of 2005''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Amendments to Public Health Service Act.
``Part C--Patient Safety Improvement
``Sec. 921. Definitions.
``Sec. 922. Privilege and confidentiality protections.
``Sec. 923. Network of patient safety databases.
``Sec. 924. Patient safety organization certification and
listing.
``Sec. 925. Technical assistance.
``Sec. 926. Severability.
SEC. 2. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42
U.S.C. 299 et seq.) is amended--
(1) in section 912(c), by inserting ``, in accordance with
part C,'' after ``The Director shall'';
(2) by redesignating part C as part D;
(3) by redesignating sections 921 through 928, as sections
931 through 938, respectively;
(4) in section 938(1) (as so redesignated), by striking
``921'' and inserting ``931''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) HIPAA confidentiality regulations.--The term `HIPAA
confidentiality regulations' means regulations promulgated
under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat.
2033).
``(2) Identifiable patient safety work product.--The term
`identifiable patient safety work product' means patient safety
work product that--
``(A) is presented in a form and manner that allows
the identification of any provider that is a subject of
the work product, or any providers that participate in
activities that are a subject of the work product;
``(B) constitutes individually identifiable health
information as that term is defined in the HIPAA
confidentiality regulations; or
``(C) is presented in a form and manner that allows
the identification of an individual who reported
information in the manner specified in section 922(e).
``(3) Nonidentifiable patient safety work product.--The
term `nonidentifiable patient safety work product' means
patient safety work product that is not identifiable patient
safety work product (as defined in paragraph (2)).
``(4) Patient safety organization.--The term `patient
safety organization' means a private or public entity or
component thereof that is listed by the Secretary pursuant to
section 924(d).
``(5) Patient safety activities.--The term `patient safety
activities' means the following activities:
``(A) Efforts to improve patient safety and the
quality of health care delivery.
``(B) The collection and analysis of patient safety
work product.
``(C) The development and dissemination of
information with respect to improving patient safety,
such as recommendations, protocols, or information
regarding best practices.
``(D) The utilization of patient safety work
product for the purposes of encouraging a culture of
safety and of providing feedback and assistance to
effectively minimize patient risk.
``(E) The maintenance of procedures to preserve
confidentiality with respect to patient safety work
product.
``(F) The provision of appropriate security
measures with respect to patient safety work product.
``(G) The utilization of qualified staff.
``(H) Activities related to the operation of a
patient safety evaluation system and to the provision
of feedback to participants in a patient safety
evaluation system.
``(6) Patient safety evaluation system.--The term `patient
safety evaluation system' means the collection, management, or
analysis of information for reporting to or by a patient safety
organization.
``(7) Patient safety work product.--
``(A) In general.--Except as provided in
subparagraph (B), the term `patient safety work
product' means any data, reports, records, memoranda,
analyses (such as root cause analyses), or written or
oral statements--
``(i) which--
``(I) are assembled or developed by
a provider for reporting to a patient
safety organization and are reported to
a patient safety organization; or
``(II) are developed by a patient
safety organization for the conduct of
patient safety activities;
and which could result in improved patient
safety, health care quality, or health care
outcomes; or
``(ii) which identify or constitute the
deliberations or analysis of, or identify the
fact of reporting pursuant to, a patient safety
evaluation system.
``(B) Clarification.--
``(i) Information described in subparagraph
(A) does not include a patient's medical
record, billing and discharge information, or
any other original patient or provider record.
``(ii) Information described in
subparagraph (A) does not include information
that is collected, maintained, or developed
separately, or exists separately, from a
patient safety evaluation system. Such separate
information or a copy thereof reported to a
patient safety organization shall not by reason
of its reporting be considered patient safety
work product.
``(iii) Nothing in this part shall be
construed to limit--
``(I) the discovery of or
admissibility of information described
in this subparagraph in a criminal,
civil, or administrative proceeding;
``(II) the reporting of information
described in this subparagraph to a
Federal, State, or local governmental
agency for public health surveillance,
investigation, or other public health
purposes or health oversight purposes;
or
``(III) a provider's recordkeeping
obligation with respect to information
described in this subparagraph under
Federal, State, or local law.
``(8) Provider.--The term `provider' means--
``(A) an individual or entity licensed or otherwise
authorized under State law to provide health care
services, including--
``(i) a hospital, nursing facility,
comprehensive outpatient rehabilitation
facility, home health agency, hospice program,
renal dialysis facility, ambulatory surgical
center, pharmacy, physician or health care
practitioner's office, long term care facility,
behavior health residential treatment facility,
clinical laboratory, or health center; or
``(ii) a physician, physician assistant,
nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist,
certified nurse midwife, psychologist,
certified social worker, registered dietitian
or nutrition professional, physical or
occupational therapist, pharmacist, or other
individual health care practitioner; or
``(B) any other individual or entity specified in
regulations promulgated by the Secretary.
``SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
``(a) Privilege.--Notwithstanding any other provision of Federal,
State, or local law, and subject to subsection (c), patient safety work
product shall be privileged and shall not be--
``(1) subject to a Federal, State, or local civil,
criminal, or administrative subpoena or order, including in a
Federal, State, or local civil or administrative disciplinary
proceeding against a provider;
``(2) subject to discovery in connection with a Federal,
State, or local civil, criminal, or administrative proceeding,
including in a Federal, State, or local civil or administrative
disciplinary proceeding against a provider;
``(3) subject to disclosure pursuant to section 552 of
title 5, United States Code (commonly known as the Freedom of
Information Act) or any other similar Federal, State, or local
law;
``(4) admitted as evidence in any Federal, State, or local
governmental civil proceeding, criminal proceeding,
administrative rulemaking proceeding, or administrative
adjudicatory proceeding, including any such proceeding against
a provider; or
``(5) admitted in a professional disciplinary proceeding of
a professional disciplinary body established or specifically
authorized under State law.
``(b) Confidentiality of Patient Safety Work Product.--
Notwithstanding any other provision of Federal, State, or local law,
and subject to subsection (c), patient safety work product shall be
confidential and shall not be disclosed.
``(c) Exceptions.--Except as provided in subsection (g)(3)--
``(1) Exceptions from privilege and confidentiality.--
Subsections (a) and (b) shall not apply to (and shall not be
construed to prohibit) one or more of the following
disclosures:
``(A) Disclosure of relevant patient safety work
product for use in a criminal proceeding, but only
after a court makes an in camera determination that
such patient safety work product contains evidence of a
criminal act and that such patient safety work product
is material to the proceeding and not reasonably
available from any other source.
``(B) Disclosure of patient safety work product to
the extent required to carry out subsection (f)(4)(A).
``(C) Disclosure of identifiable patient safety
work product if authorized by each provider identified
in such work product.
``(2) Exceptions from confidentiality.--Subsection (b)
shall not apply to (and shall not be construed to prohibit) one
or more of the following disclosures:
``(A) Disclosure of patient safety work product to
carry out patient safety activities.
``(B) Disclosure of nonidentifiable patient safety
work product.
``(C) Disclosure of patient safety work product to
grantees, contractors, or other entities carrying out
research, evaluation, or demonstration projects
authorized, funded, certified, or otherwise sanctioned
by rule or other means by the Secretary, for the
purpose of conducting research to the extent that
disclosure of protected health information would be
allowed for such purpose under the HIPAA
confidentiality regulations.
``(D) Disclosure by a provider to the Food and Drug
Administration with respect to a product or activity
regulated by the Food and Drug Administration.
``(E) Voluntary disclosure of patient safety work
product by a provider to an accrediting body that
accredits that provider.
``(F) Disclosures that the Secretary may determine,
by rule or other means, are necessary for business
operations and are consistent with the goals of this
part.
``(G) Disclosure of patient safety work product to
law enforcement authorities relating to the commission
of a crime (or to an event reasonably believed to be a
crime) if the person making the disclosure believes,
reasonably under the circumstances, that the patient
safety work product that is disclosed is necessary for
criminal law enforcement purposes.
``(H) With respect to a person other than a patient
safety organization, the disclosure of patient safety
work product that does not include materials that--
``(i) assess the quality of care of an
identifiable provider; or
``(ii) describe or pertain to one or more
actions or failures to act by an identifiable
provider.
``(3) Exception from privilege.--Subsection (a) shall not
apply to (and shall not be construed to prohibit) voluntary
disclosure of nonidentifiable patient safety work product.
``(d) Continued Protection of Information After Disclosure.--
``(1) In general.--Patient safety work product that is
disclosed under subsection (c) shall continue to be privileged
and confidential as provided for in subsections (a) and (b),
and such disclosure shall not be treated as a waiver of
privilege or confidentiality, and the privileged and
confidential nature of such work product shall also apply to
such work product in the possession or control of a person to
whom such work product was disclosed.
``(2) Exception.--Notwithstanding paragraph (1), and
subject to paragraph (3)--
``(A) if patient safety work product is disclosed
in a criminal proceeding, the confidentiality
protections provided for in subsection (b) shall no
longer apply to the work product so disclosed; and
``(B) if patient safety work product is disclosed
as provided for in subsection (c)(2)(B) (relating to
disclosure of nonidentifiable patient safety work
product), the privilege and confidentiality protections
provided for in subsections (a) and (b) shall no longer
apply to such work product.
``(3) Construction.--Paragraph (2) shall not be construed
as terminating or limiting the privilege or confidentiality
protections provided for in subsection (a) or (b) with respect
to patient safety work product other than the specific patient
safety work product disclosed as provided for in subsection
(c).
``(4) Limitations on actions.--
``(A) Patient safety organizations.--
``(i) In general.--A patient safety
organization shall not be compelled to disclose
information collected or developed under this
part whether or not such information is patient
safety work product unless such information is
identified, is not patient safety work product,
and is not reasonably available from another
source.
``(ii) Nonapplication.--The limitation
contained in clause (i) shall not apply in an
action against a patient safety organization or
with respect to disclosures pursuant to
subsection (c)(1).
``(B) Providers.--An accrediting body shall not take an
accrediting action against a provider based on the good faith
participation of the provider in the collection, development,
reporting, or maintenance of patient safety work product in
accordance with this part. An accrediting body may not require
a provider to reveal its communications with any patient safety
organization established in accordance with this part.
``(e) Reporter Protection.--
``(1) In general.--A provider may not take an adverse
employment action, as described in paragraph (2), against an
individual based upon the fact that the individual in good
faith reported information--
``(A) to the provider with the intention of having
the information reported to a patient safety
organization; or
``(B) directly to a patient safety organization.
``(2) Adverse employment action.--For purposes of this
subsection, an `adverse employment action' includes--
``(A) loss of employment, the failure to promote an
individual, or the failure to provide any other
employment-related benefit for which the individual
would otherwise be eligible; or
``(B) an adverse evaluation or decision made in
relation to accreditation, certification,
credentialing, or licensing of the individual.
``(f) Enforcement.--
``(1) Civil monetary penalty.--Subject to paragraphs (2)
and (3), a person who discloses identifiable patient safety
work product in knowing or reckless violation of subsection (b)
shall be subject to a civil monetary penalty of not more than
$10,000 for each act constituting such violation.
``(2) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsections (a) and (b) and the
first sentence of subsection (c)(1), shall apply to civil money
penalties under this subsection in the same manner as such
provisions apply to a penalty or proceeding under section 1128A
of the Social Security Act.
``(3) Relation to hipaa.--Penalties shall not be imposed
both under this subsection and under the regulations issued
pursuant to section 264(c)(1) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note) for a single act or omission.
``(4) Equitable relief.--
``(A) In general.--Without limiting remedies
available to other parties, a civil action may be
brought by any aggrieved individual to enjoin any act
or practice that violates subsection (e) and to obtain
other appropriate equitable relief (including
reinstatement, back pay, and restoration of benefits)
to redress such violation.
``(B) Against state employees.--An entity that is a
State or an agency of a State government may not assert
the privilege described in subsection (a) unless before
the time of the assertion, the entity or, in the case
of and with respect to an agency, the State has
consented to be subject to an action described in
subparagraph (A), and that consent has remained in
effect.
``(g) Rule of Construction.--Nothing in this section shall be
construed--
``(1) to limit the application of other Federal, State, or
local laws that provide greater privilege or confidentiality
protections than the privilege and confidentiality protections
provided for in this section;
``(2) to limit, alter, or affect the requirements of
Federal, State, or local law pertaining to information that is
not privileged or confidential under this section;
``(3) except as provided in subsection (i), to alter or
affect the implementation of any provision of the HIPAA
confidentiality regulations or section 1176 of the Social
Security Act (or regulations promulgated under such section);
``(4) to limit the authority of any provider, patient
safety organization, or other entity to enter into a contract
requiring greater confidentiality or delegating authority to
make a disclosure or use in accordance with this section;
``(5) as preempting or otherwise affecting any State law
requiring a provider to report information that is not patient
safety work product; or
``(6) to limit, alter, or affect any requirement for
reporting to the Food and Drug Administration information
regarding the safety of a product or activity regulated by the
Food and Drug Administration.
``(h) Clarification.--Nothing in this part prohibits any person
from conducting additional analysis for any purpose regardless of
whether such additional analysis involves issues identical to or
similar to those for which information was reported to or assessed by a
patient safety organization or a patient safety evaluation system.
``(i) Clarification of application of hipaa confidentiality
regulations to patient safety organizations.--For purposes of applying
the HIPAA confidentiality regulations--
``(1) patient safety organizations shall be treated as
business associates; and
``(2) patient safety activities of such organizations in
relation to a provider are deemed to be health care operations
(as defined in such regulations) of the provider.
``(j) Reports on Strategies to Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18
months after any network of patient safety databases is
operational, the Secretary, in consultation with the Director,
shall prepare a draft report on effective strategies for
reducing medical errors and increasing patient safety. The
draft report shall include any measure determined appropriate
by the Secretary to encourage the appropriate use of such
strategies, including use in any federally funded programs. The
Secretary shall make the draft report available for public
comment and submit the draft report to the Institute of
Medicine for review.
``(2) Final report.--Not later than 1 year after the date
described in paragraph (1), the Secretary shall submit a final
report to the Congress.
``SEC. 923. NETWORK OF PATIENT SAFETY DATABASES.
``(a) In General.--The Secretary shall facilitate the creation of,
and maintain, a network of patient safety databases that provides an
interactive evidence-based management resource for providers, patient
safety organizations, and other entities. The network of databases
shall have the capacity to accept, aggregate across the network, and
analyze nonidentifiable patient safety work product voluntarily
reported by patient safety organizations, providers, or other entities.
The Secretary shall assess the feasibility of providing for a single
point of access to the network for qualified researchers for
information aggregated across the network and, if feasible, provide for
implementation.
``(b) Data Standards.--The Secretary may determine common formats
for the reporting to and among the network of patient safety databases
maintained under subsection (a) of nonidentifiable patient safety work
product, including necessary work product elements, common and
consistent definitions, and a standardized computer interface for the
processing of such work product. To the extent practicable, such
standards shall be consistent with the administrative simplification
provisions of part C of title XI of the Social Security Act.
``(c) Use of Information.--Information reported to and among the
network of patient safety databases under subsection (a) shall be used
to analyze national and regional statistics, including trends and
patterns of health care errors. The information resulting from such
analyses shall be made available to the public and included in the
annual quality reports prepared under section 913(b)(2).
``SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.
``(a) Certification.--
``(1) Initial certification.--An entity that seeks to be a
patient safety organization shall submit an initial
certification to the Secretary that the entity--
``(A) has policies and procedures in place to
perform each of the patient safety activities described
in section 921(5); and
``(B) upon being listed under subsection (d), will
comply with the criteria described in subsection (b).
``(2) Subsequent certifications.--An entity that is a
patient safety organization shall submit every 3 years after
the date of its initial listing under subsection (d) a
subsequent certification to the Secretary that the entity--
``(A) is performing each of the patient safety
activities described in section 921(5); and
``(B) is complying with the criteria described in
subsection (b).
``(b) Criteria.--
``(1) In general.--The following are criteria for the
initial and subsequent certification of an entity as a patient
safety organization:
``(A) The mission and primary activity of the
entity are to conduct activities that are to improve
patient safety and the quality of health care delivery.
``(B) The entity has appropriately qualified staff
(whether directly or through contract), including
licensed or certified medical professionals.
``(C) The entity, within each 24-month period that
begins after the date of the initial listing under
subsection (d), has bona fide contracts, each of a
reasonable period of time, with more than 1 provider
for the purpose of receiving and reviewing patient
safety work product.
``(D) The entity is not, and is not a component of,
a health insurance issuer (as defined in section
2791(b)(2)).
``(E) The entity shall fully disclose--
``(i) any financial, reporting, or
contractual relationship between the entity and
any provider that contracts with the entity;
and
``(ii) if applicable, the fact that the
entity is not managed, controlled, and operated
independently from any provider that contracts
with the entity.
``(F) To the extent practical and appropriate, the
entity collects patient safety work product from
providers in a standardized manner that permits valid
comparisons of similar cases among similar providers.
``(G) The utilization of patient safety work
product for the purpose of providing direct feedback
and assistance to providers to effectively minimize
patient risk.
``(2) Additional criteria for component organizations.--If
an entity that seeks to be a patient safety organization is a
component of another organization, the following are additional
criteria for the initial and subsequent certification of the
entity as a patient safety organization:
``(A) The entity maintains patient safety work
product separately from the rest of the organization,
and establishes appropriate security measures to
maintain the confidentiality of the patient safety work
product.
``(B) The entity does not make an unauthorized
disclosure under this part of patient safety work
product to the rest of the organization in breach of
confidentiality.
``(C) The mission of the entity does not create a
conflict of interest with the rest of the organization.
``(c) Review of Certification.--
``(1) In general.--
``(A) Initial certification.--Upon the submission
by an entity of an initial certification under
subsection (a)(1), the Secretary shall determine if the
certification meets the requirements of subparagraphs
(A) and (B) of such subsection.
``(B) Subsequent certification.--Upon the
submission by an entity of a subsequent certification
under subsection (a)(2), the Secretary shall review the
certification with respect to requirements of
subparagraphs (A) and (B) of such subsection.
``(2) Notice of acceptance or non-acceptance.--If the
Secretary determines that--
``(A) an entity's initial certification meets
requirements referred to in paragraph (1)(A), the
Secretary shall notify the entity of the acceptance of
such certification; or
``(B) an entity's initial certification does not
meet such requirements, the Secretary shall notify the
entity that such certification is not accepted and the
reasons therefor.
``(3) Disclosures regarding relationship to providers.--The
Secretary shall consider any disclosures under subsection
(b)(1)(E) by an entity and shall make public findings on
whether the entity can fairly and accurately perform the
patient safety activities of a patient safety organization. The
Secretary shall take those findings into consideration in
determining whether to accept the entity's initial
certification and any subsequent certification submitted under
subsection (a) and, based on those findings, may deny,
condition, or revoke acceptance of the entity's certification.
``(d) Listing.--The Secretary shall compile and maintain a listing
of entities with respect to which there is an acceptance of a
certification pursuant to subsection (c)(2)(A) that has not been
revoked under subsection (e) or voluntarily relinquished.
``(e) Revocation of Acceptance of Certification.--
``(1) In general.--If, after notice of deficiency, an
opportunity for a hearing, and a reasonable opportunity for
correction, the Secretary determines that a patient safety
organization does not meet the certification requirements under
subsection (a)(2), including subparagraphs (A) and (B) of such
subsection, the Secretary shall revoke the Secretary's
acceptance of the certification of such organization.
``(2) Supplying confirmation of notification to
providers.--Within 15 days of a revocation under paragraph (1),
a patient safety organization shall submit to the Secretary a
confirmation that the organization has taken all reasonable
actions to notify each provider whose patient safety work
product is collected or analyzed by the organization of such
revocation.
``(3) Publication of decision.--If the Secretary revokes
the certification of an organization under paragraph (1), the
Secretary shall--
``(A) remove the organization from the listing
maintained under subsection (d); and
``(B) publish notice of the revocation in the
Federal Register.
``(f) Status of Data After Removal from Listing.--
``(1) New data.--With respect to the privilege and
confidentiality protections described in section 922, data
submitted to an entity within 30 days after the entity is
removed from the listing under subsection (e)(3)(A) shall have
the same status as data submitted while the entity was still
listed.
``(2) Protection to continue to apply.--If the privilege
and confidentiality protections described in section 922
applied to patient safety work product while an entity was
listed, or to data described in paragraph (1), such protections
shall continue to apply to such work product or data after the
entity is removed from the listing under subsection (e)(3)(A).
``(g) Disposition of Work Product and Data.--If the Secretary
removes a patient safety organization from the listing as provided for
in subsection (e)(3)(A), with respect to the patient safety work
product or data described in subsection (f)(1) that the patient safety
organization received from another entity, such former patient safety
organization shall--
``(1) with the approval of the other entity and a patient
safety organization, transfer such work product or data to such
patient safety organization;
``(2) return such work product or data to the entity that
submitted the work product or data; or
``(3) if returning such work product or data to such entity
is not practicable, destroy such work product or data.
``SEC. 925. TECHNICAL ASSISTANCE.
``The Secretary, acting through the Director, may provide technical
assistance to patient safety organizations, including convening annual
meetings for patient safety organizations to discuss methodology,
communication, data collection, or privacy concerns.
``SEC. 926. SEVERABILITY.
``If any provision of this part is held to be unconstitutional, the
remainder of this part shall not be affected.''.
(b) Authorization of Appropriations.--Section 937 of the Public
Health Service Act (as redesignated by subsection (a)) is amended by
adding at the end the following:
``(e) Patient Safety and Quality Improvement.--For the purpose of
carrying out part C, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2006 through 2010.''.
(c) GAO Study on Implementation.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the effectiveness of part C of title
IX of the Public Health Service Act (as added by subsection
(a)) in accomplishing the purposes of such part.
(2) Report.--Not later than February 1, 2010, the
Comptroller General shall submit a report on the study
conducted under paragraph (1). Such report shall include such
recommendations for changes in such part as the Comptroller
General deems appropriate.
Passed the Senate July 21, 2005.
Attest:
Secretary.
109th CONGRESS
1st Session
S. 544
_______________________________________________________________________
AN ACT
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events
that adversely effect patient safety.